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NCT05533866 Clinical Trial

Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

Epidermolysis Bullosa Clinical Trial

Official title:
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05533866
Other study ID # 2022-5523
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date February 6, 2023
Est. completion date December 2024

Study information
Verified date January 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 17
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility Inclusion Criteria: - Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa - Target wound that has been present for at least 3 weeks and is at least 10 cm2 - Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa Exclusion Criteria: - Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics - Do not agree to avoid bathing or topical application at the target starting the night before the visit. - Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• APR-TD011
APR-TD011 wound cleansing spray (drug/device combination product with a 510k clearance that is commercially marketed in the US for use by or on the order of a physician. Based on its product profile, APR-TD011 has been granted an FDA Orphan Drug Designation for epidermolysis bullosa.

Locations
Country Name City State
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in microbiome species Reduction of Staphylococcus aureus between baseline and Week 8. 8 weeks
See also
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